Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures

• Sponsor: Osteotech, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00837473
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where bone was removed or "harvested") for the back surgery.

The study will be focusing on patients who require back surgery. Often additional bone is required from the hip of the patient (iliac crest). When bone removed from the hip, a "void" is often created. This "void" will be filled in with Osteotech's Plexur P product.

Condition or Disease	Intervention/Treatment	Phase
Iliac Crest Harvesting Procedure-Bone Void Filler	Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures	N/A

Detailed Description

This prospective trial is designed to evaluate the ability of the Plexur P device (bone void filler) to reconstitute the iliac crest in patients requiring iliac crest bone harvesting procedures at one single study site.

Plexur P Bone Void Filler is:

• A biocomposite of mineralized cortical allograft bone fibers and polylactide-co-glycolide co-polymer.

• Designed to fill bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.

• Porosity is introduced into the Plexur P Biocomposites to create a cancellous-like structure that provides a scaffold for bone growth.

In addition:

• Patients will be screened for study eligibility based on the need for iliac crest bone harvesting.

• Fifteen (15) eligible patients will be enrolled and will have an iliac crest harvesting defect backfilled with Plexur P to repair the iliac crest defect.

• As a part of routine follow up care, patient related outcomes including measurements of pain severity and pain relief will be determined using patient (IRB approved) questionnaires.

• Radiographic analysis will also be used to determine amount of bony ingrowth of the Plexur P device.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Pilot Study on the Performance of The Plexur P™ Bone Void Filler
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Plexur-P Bone Void Filler Single arm. Open Label.	Device: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures; Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist [6 wks, 3 mths, 6 mths 12 mths, and 24 mths]

   Reconstitution of bone growth was determined by an independent radiologist based on bony ingrowth and absence of a gap according to the following criteria: Absent: limited or no bone mineralization visualized at the defect site; extensive areas of radiolucency. Mild: identifiable bone mineralization and coalescence of the bone graft mass of < 50% of the defect site. Moderate: identifiable bone mineralization and coalescence of the bone graft mass over > 50% of the defect site; some remaining unmineralized areas of radiolucency; limited evidence of partial bone remodeling and trabeculation. Extensive: > 75% of bone mineralization over the defect site showing a contiguous and completely coalesced bone graft mass with confluent trabecular pattern.

Secondary Outcome Measures

1. General Health Status [Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths]

   The general health status was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36v2). The SF-36v2 questionnaire contains 36 questions pertaining to eight subscales of health status. These eight subscales can be summarized as relating to either physical health or mental health. The physical component summary (PCS) is based primarily on the physical functioning, role-physical, bodily pain, and general health scales of the SF-36v2 survey. The mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.

2. Oswestry Disability Index [Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths]

   The Oswestry Disability Index (ODI) is an internationally validated questionnaire consisting of ten sets of statements which focus on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and ability to travel. ODI scores are in a range of 0 to 100, with a lower score indicating less pain and disability and higher scores indicating more pain and disability.

3. Pain Status Assessed by Visual Analog Scale (VAS) [Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths]

   The visual analog scale (VAS) was used for assessing pain status in the body locations of back/neck, left leg/arm, and right arm/leg. Subjects were asked to rate their perception of pain in VAS, generated by the Osteotech Clinical Department. The scale from 1 to 5 represented the pain levels at none, mild, average, severe, and extreme.

4. Surgical Related Outcome--locations of Iliac Crest Bone Harvest [During the time of operation, a range of 2.5-8.5 hrs]

5. Surgical outcome-the Amount of Cancellous Bone Harvested [During the time of operation, a range of 2.5-8.5 hrs]

6. Surgical Outcome--operative Time [The time of operation, a range of 2.5-8.5 hrs]

7. Surgical Outcome--blood Loss [During the time of operation, a range of 2.5-8.5 hrs]

8. Surgical Outcome--length of Hospital Stay [From admission to discharge, a range of 2 to 20 days]

9. Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void [During the time of operation, a range of 2.5-8.5 hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient is at least 18 yrs old.

• The patient requires an iliac crest harvesting procedure.

• The patient has signed an Informed Consent, approved by the IRB.

Exclusion Criteria:

• Patient is less than 18 years old.

• Patient presents with a bony void or gap in an area other than the iliac crest and/or has an infection present at the (operative) site.

• Insulin dependent diabetics and/or in the opinion of the investigator, has poorly controlled non-insulin dependent diabetes.

• The patient is a smoker.

• The patient is mentally compromised (e.g., currently being treated from a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) and/or in the opinion of the investigator, is not likely to complete follow up visits;

• The patient has a bleeding disorder of any etiology, severe vascular or neurological disease;

• The patient has hypercalcemia and/or severe degenerative bone disease;

• The patient has a history of long term steroid use;

• The patient requires immunosuppressive therapy;

• The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent;

• The patient is pregnant at the time of study entry or may likely become pregnant during the course of study participation;

• The subject has an implanted device, which is incompatible with the use of imaging equipment;

• The patient has an allergy to one of the components of the investigational device;

• The patient has renal insufficiency;

• The patient has a terminal illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Osteotech, Inc

Investigators

• Principal Investigator: Oheneba Boachie-Adijei, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Osteotech, Inc
• ClinicalTrials.gov Identifier: NCT00837473
• Other Study ID Numbers: Trial #3206
• First Posted: Feb 5, 2009
• Last Update Posted: Apr 30, 2018
• Last Verified: Sep 1, 2012

• Keywords provided by Osteotech, Inc: Bone Void Filler; Iliac Crest Bone Void Filler; Back Surgery and Autograft Bone; Autograft Bone; Allograft Bone
• Additional relevant MeSH terms: CREST Syndrome

Study Results

Participant Flow

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Period Title: Overall Study
STARTED	15
COMPLETED	12
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.13 (9.45)
Sex: Female, Male (Count of Participants)
Female	13 86.7%
Male	2 13.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist
Description	Reconstitution of bone growth was determined by an independent radiologist based on bony ingrowth and absence of a gap according to the following criteria: Absent: limited or no bone mineralization visualized at the defect site; extensive areas of radiolucency. Mild: identifiable bone mineralization and coalescence of the bone graft mass of < 50% of the defect site. Moderate: identifiable bone mineralization and coalescence of the bone graft mass over > 50% of the defect site; some remaining unmineralized areas of radiolucency; limited evidence of partial bone remodeling and trabeculation. Extensive: > 75% of bone mineralization over the defect site showing a contiguous and completely coalesced bone graft mass with confluent trabecular pattern.
Time Frame	6 wks, 3 mths, 6 mths 12 mths, and 24 mths

Outcome Measure Data

Analysis Population Description

The primary analysis dataset included all study subjects with available data.

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Absent	11 73.3%
Mild	4 26.7%
Moderate	0 0%
Extensive	0 0%
Absent	3 20%
Mild	1 6.7%
Moderate	1 6.7%
Extensive	0 0%
Absent	0 0%
Mild	10 66.7%
Moderate	2 13.3%
Extensive	0 0%
Absent	0 0%
Mild	6 40%
Moderate	6 40%
Extensive	1 6.7%
Absent	0 0%
Mild	1 6.7%
Moderate	9 60%
Extensive	2 13.3%

2. Secondary Outcome

Title	General Health Status
Description	The general health status was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36v2). The SF-36v2 questionnaire contains 36 questions pertaining to eight subscales of health status. These eight subscales can be summarized as relating to either physical health or mental health. The physical component summary (PCS) is based primarily on the physical functioning, role-physical, bodily pain, and general health scales of the SF-36v2 survey. The mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.
Time Frame	Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths

Outcome Measure Data

Analysis Population Description

The primary analysis dataset included all study subjects with available data.

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
SF-36 PCS score at baseline	35.36 (8.67)
SF-36 PCS score at 6 weeks	29.41 (8.51)
SF-36 PCS score at 3 months	35.68 (10.36)
SF-36 PCS score at 6 months	41.68 (10.77)
SF-36 PCS score at 12 months	41.23 (12.25)
SF-36 PCS score at 24 months	37.43 (14.90)
SF-36 MCS score at baseline	43.86 (12.74)
SF-36 MCS score at 6 weeks	45.91 (14.38)
SF-36 MCS score at 3 months	54.50 (9.98)
SF-36 MCS score at 6 months	50.36 (16.24)
SF-36 MCS score at 12 months	49.69 (12.72)
SF-36 MCS score at 24 months	44.87 (11.35)

3. Secondary Outcome

Title	Oswestry Disability Index
Description	The Oswestry Disability Index (ODI) is an internationally validated questionnaire consisting of ten sets of statements which focus on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and ability to travel. ODI scores are in a range of 0 to 100, with a lower score indicating less pain and disability and higher scores indicating more pain and disability.
Time Frame	Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths

Outcome Measure Data

Analysis Population Description

The primary analysis dataset included all study subjects with available data.

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
ODI at baseline	54.28 (17.88)
ODI at 6 wks	70.19 (15.95)
ODI at 3 months	56.44 (20.26)
ODI at 6 months	44.86 (16.71)
ODI at 12 months	41.92 (20.03)
ODI at 24 months	50.80 (19.94)

4. Secondary Outcome

Title	Pain Status Assessed by Visual Analog Scale (VAS)
Description	The visual analog scale (VAS) was used for assessing pain status in the body locations of back/neck, left leg/arm, and right arm/leg. Subjects were asked to rate their perception of pain in VAS, generated by the Osteotech Clinical Department. The scale from 1 to 5 represented the pain levels at none, mild, average, severe, and extreme.
Time Frame	Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths

Outcome Measure Data

Analysis Population Description

The primary analysis dataset included all study subjects with available data.

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Back/neck pain at baseline	3.5 (1.4)
Back/neck pain at 6 weeks	2.6 (1.2)
Back/neck pain at 3 months	2.3 (1.5)
Back/neck pain at 6 months	2.4 (1.1)
Back/neck pain at 12 months	2.1 (1.0)
Back/neck pain at 24 months	2.8 (1.5)
Left leg/arm pain at baseline	2.0 (1.2)
Left leg/arm pain at 6 weeks	2.1 (1.2)
Left leg/arm pain at 3 months	1.7 (0.6)
Left leg/arm pain at 6 months	1.7 (0.8)
Left leg/arm pain at 12 months	1.9 (1.4)
Left leg/arm pain at 24 months	2.0 (1.4)
Right leg/arm pain at baseline	2.0 (1.1)
Right leg/arm pain at 6 weeks	1.9 (0.9)
Right leg/arm pain at 3 months	1.7 (1.2)
Right leg/arm pain at 6 months	1.6 (0.8)
Right leg/arm pain at 12 months	1.8 (1.5)
Right leg/arm pain at 24 months	2.1 (1.3)

5. Secondary Outcome

Title	Surgical Related Outcome--locations of Iliac Crest Bone Harvest
Time Frame	During the time of operation, a range of 2.5-8.5 hrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Left side	8 53.3%
Right side	7 46.7%

6. Secondary Outcome

Title	Surgical outcome-the Amount of Cancellous Bone Harvested
Time Frame	During the time of operation, a range of 2.5-8.5 hrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Mean (Standard Deviation) [cc]	14.6 (5.4)

7. Secondary Outcome

Title	Surgical Outcome--operative Time
Time Frame	The time of operation, a range of 2.5-8.5 hrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Mean (Standard Deviation) [min]	310.0 (97.2)

8. Secondary Outcome

Title	Surgical Outcome--blood Loss
Time Frame	During the time of operation, a range of 2.5-8.5 hrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Mean (Standard Deviation) [ml]	1786.7 (1128.8)

9. Secondary Outcome

Title	Surgical Outcome--length of Hospital Stay
Time Frame	From admission to discharge, a range of 2 to 20 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Mean (Standard Deviation) [days]	10.7 (4.6)

10. Secondary Outcome

Title	Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void
Time Frame	During the time of operation, a range of 2.5-8.5 hrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
Measure Participants	15
Mean (Standard Deviation) [cc]	24.7 (5.6)

Adverse Events

Time Frame	Overall study period, up to 24 months
Adverse Event Reporting Description	All adverse events that observed by the investigator or reported spontaneously by the study participants were recorded on the Clinical Complication/Adverse Event Form by the investigator.
Arm/Group Title	Plexur-P Bone Void Filler
Arm/Group Description	Single arm. Open Label. Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures: Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
All Cause Mortality
	Plexur-P Bone Void Filler
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Plexur-P Bone Void Filler
	Affected / at Risk (%)	# Events
Total	12/15 (80%)
Endocrine disorders
Other	1/15 (6.7%)	1
General disorders
Other	1/15 (6.7%)	1
Infections and infestations
Infection other	1/15 (6.7%)	1
Other	1/15 (6.7%)	1
Injury, poisoning and procedural complications
Other	5/15 (33.3%)	6
Metabolism and nutrition disorders
Other	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Other	1/15 (6.7%)	1
Nervous system disorders
Other	1/15 (6.7%)	1
Product Issues
Other	3/15 (20%)	4
Respiratory, thoracic and mediastinal disorders
Other	3/15 (20%)	5
Vascular disorders
Other	1/15 (6.7%)	1
Other (Not Including Serious) Adverse Events
	Plexur-P Bone Void Filler
	Affected / at Risk (%)	# Events
Total	14/15 (93.3%)
Cardiac disorders
Other	1/15 (6.7%)	1
Gastrointestinal disorders
Ileus	3/15 (20%)	3
General disorders
Edema	2/15 (13.3%)	2
Other	1/15 (6.7%)	1
Infections and infestations
Infection, other	2/15 (13.3%)	2
Infection, operative site	1/15 (6.7%)	1
Other	2/15 (13.3%)	2
Injury, poisoning and procedural complications
Other	1/15 (6.7%)	1
Investigations
Other	3/15 (20%)	3
Metabolism and nutrition disorders
Other	1/15 (6.7%)	1
Musculoskeletal and connective tissue disorders
Other	1/15 (6.7%)	1
Nervous system disorders
Other	2/15 (13.3%)	2
Renal and urinary disorders
Urine Retention	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
Other	9/15 (60%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.